Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection

NCT05526729 | Completed

• 1 other identifier: CRTH258B1401
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 76

Brief Summary

This was a primary data collection-based observational special drug-use surveillance to be conducted in accordance with the Good Post-marketing Study Practice (GPSP) ordinance.

Conditions

Diabetic Macular Edema

Keywords

diabetic macular edema; DME; NIS; Japan; PMS; Beovu

Outcome Measures

Primary Outcomes (3)

• Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period

  Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period was collected. Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion

  Up to 52 weeks

• Proportions of patients with adverse events in the eyes on therapy during the observation period

  Proportions of patients with adverse events in the eyes on therapy during the observation period was collected

  Up to 52 weeks

• Proportion of patients with systemic adverse events during the observation period

  Proportion of patients with systemic (non-ocular) adverse events during the observation period was collected

  Up to 52 weeks

Secondary Outcomes (7)

• Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period

  Up to 52 weeks

• Proportion of patients with systemic SAEs and adverse reactions during the observation period

  Up to 52 weeks

• Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period

  Up to 52 weeks

• Incidences of adverse events by risk factor of the safety specifications

  Up to 52 weeks

• Proportion of patients with VA worsening during the observation period

  Up to 52 weeks

Study Arms (1)

Beovu

Patients prescribed with Beovu for diabetic macular edema

Other: Beovu

Interventions

Beovu OTHER

Prospective observational study. There was no treatment allocation. Patients prescribed with Beovu for the first time for diabetic macular edema were eligible to enroll into this study.

Also known as: Brolucizumab

Beovu

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients using Beovu for the first time for diabetic macular edema in Japan

You may qualify if:

• Patients must provide written consent to cooperate in this study before the start of treatment with Beovu
• Patients using Beovu for the first time for the following indication • Indication: diabetic macular edema

You may not qualify if:

• \. Patients with a history of treatment with a drug containing the same ingredient (brolucizumab) as Beovu

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (76)

Novartis Investigative Site

Nagakute, Aichi-ken, 480-1195, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 457 8510, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 460-0008, Japan

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 462-0825, Japan

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Novartis Investigative Site

Nagoya, Aichi-ken, 466-8650, Japan

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Novartis Investigative Site

Nagoya, Aichi-ken, 467-8602, Japan

Location

Novartis Investigative Site

Kashiwa, Chiba, 277-0004, Japan

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Novartis Investigative Site

Kisarazu, Chiba, 292-8535, Japan

Location

Novartis Investigative Site

Urayasu, Chiba, 279-0011, Japan

Location

Novartis Investigative Site

Urayasu, Chiba, 279-0021, Japan

Location

Novartis Investigative Site

Yoshida-gun, Fukui, 910-1193, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 810-8563, Japan

Location

Novartis Investigative Site

Fukuoka, Fukuoka, 812-8582, Japan

Location

Novartis Investigative Site

Kurume, Fukuoka, 830-0011, Japan

Location

Novartis Investigative Site

Fukushima, Fukushima, 960 1295, Japan

Location

Novartis Investigative Site

Mizunami, Gifu, 509-6108, Japan

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Novartis Investigative Site

Maebashi, Gunma, 371 8511, Japan

Location

Novartis Investigative Site

Asahikawa, Hokkaido, 078 8510, Japan

Location

Novartis Investigative Site

Hakodate, Hokkaido, 041-0851, Japan

Location

Novartis Investigative Site

Hakodat, Hokkaido, 041-0806, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060 8648, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-8604, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 650-0047, Japan

Location

Novartis Investigative Site

Kobe, Hyōgo, 652-0863, Japan

Location

Novartis Investigative Site

Nishinomiya, Hyōgo, 662-0918, Japan

Location

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Sumoto, Hyōgo, 656-0101, Japan

Location

Novartis Investigative Site

Takarazuka, Hyōgo, 665-0061, Japan

Location

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Inashiki, Ibaraki, 300 0395, Japan

Location

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Ishioka, Ibaraki, 315-0037, Japan

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Mito, Ibaraki, 310-0845, Japan

Location

Novartis Investigative Site

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Novartis Investigative Site

Kagoshima, Kagoshima-ken, 890 8520, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 245-0006, Japan

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Novartis Investigative Site

Nankoku, Kochi, 783 8505, Japan

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Arao, Kumamoto, 864-0041, Japan

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Kyoto, Kyoto, 606-8397, Japan

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Yokkaichi, Mie-ken, 510-8567, Japan

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Miyakonojō, Miyazaki, 885-0000, Japan

Location

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Matsumoto, Nagano, 390-8621, Japan

Location

Novartis Investigative Site

Ueda, Nagano, 386-0018, Japan

Location

Novartis Investigative Site

Nagasaki, Nagasaki, 852-8055, Japan

Location

Novartis Investigative Site

Nagasaki, Nagasaki, 852-8501, Japan

Location

Novartis Investigative Site

Nagasaki, Nagasaki, 852-8511, Japan

Location

Novartis Investigative Site

Kashihara, Nara, 634 8522, Japan

Location

Novartis Investigative Site

Jōetsu, Niigata, 943-0832, Japan

Location

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Sanjō, Niigata, 955-0852, Japan

Location

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Ōita, Oita Prefecture, 870-0852, Japan

Location

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Yufu, Oita Prefecture, 879-5593, Japan

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Novartis Investigative Site

Kurashiki, Okayama-ken, 710-8602, Japan

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Novartis Investigative Site

Okayama, Okayama-ken, 701-0153, Japan

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Novartis Investigative Site

Hirakata, Osaka, 573-1191, Japan

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Novartis Investigative Site

Moriguchi, Osaka, 570-8507, Japan

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Novartis Investigative Site

Osaka, Osaka, 545-8586, Japan

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Novartis Investigative Site

Ōsaka-sayama, Osaka, 589 8511, Japan

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Novartis Investigative Site

Sakai, Osaka, 593-8304, Japan

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Novartis Investigative Site

Suita, Osaka, 565 0871, Japan

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Novartis Investigative Site

Iruma-gun, Saitama, 350-0495, Japan

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Ohtsu, Shiga, 520-2192, Japan

Location

Novartis Investigative Site

Oda, Shimane, 694-0064, Japan

Location

Novartis Investigative Site

Shimotsuke, Tochigi, 329-0498, Japan

Location

Novartis Investigative Site

Bunkyo Ku, Tokyo, 113 8655, Japan

Location

Novartis Investigative Site

Chiyoda-ku, Tokyo, 101-8309, Japan

Location

Novartis Investigative Site

Edogawa City, Tokyo, 134-0088, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 192-0081, Japan

Location

Novartis Investigative Site

Hachiōji, Tokyo, 193-0944, Japan

Location

Novartis Investigative Site

Itabashi-ku, Tokyo, 174-0053, Japan

Location

Novartis Investigative Site

Katsushika-ku, Tokyo, 125-8506, Japan

Location

Novartis Investigative Site

Musashino, Tokyo, 180-0023, Japan

Location

Novartis Investigative Site

Taito-ku, Tokyo, 111-0051, Japan

Location

Novartis Investigative Site

Toyama, Toyama, 930-0194, Japan

Location

Novartis Investigative Site

Akita, 010-8543, Japan

Location

Novartis Investigative Site

Kumamoto, 860-8556, Japan

Location

Novartis Investigative Site

Kyoto, 6040837, Japan

Location

Novartis Investigative Site

Okayama, 700-0024, Japan

Location

Novartis Investigative Site

Osaka, 533-0024, Japan

Location

Novartis Investigative Site

Osaka, 543-0027, Japan

Location

Related Links

• Results for CRTH258B1401 that is getting linked from the Novartis Clinical Trials Website

MeSH Terms

Interventions

brolucizumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: September 2, 2022
• Primary Completion: June 29, 2024
• Study Completion: June 29, 2024
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (76)